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Organ Protection by Remote Ischemic Preconditioning for Surgical Treatment of Pediatric Congenital Heart Disease

NCT ID: NCT01312623

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-05-31

Brief Summary

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Cardiac surgery is associated with risk of perioperative inflammation and ischemia leading to cerebral and myocardial morbidity and mortality. Ischemic preconditioning by repetitive ischemic episodes at an organ can reduce damage resulting from consecutive prolonged ischemia in that organ. Remote ischemic preconditioning is defined as ischemic preconditioning by repetitive ischemic episodes of an organ remote from the organ to be protected, e.g. ischemic episodes of a limb can reduce ischemic damage of the heart. Animal studies as well as human studies have shown that ischemic preconditioning can protect the heart from intraoperative ischemia. Remote preconditioning by repetitive limb ischemia has been applied in humans in some studies.12-14 However, the published data is not yet sufficient to support evidence based recommendations for clinical practice. In particular, available data regarding the influence of remote preconditioning on inflammatory and ischemic damage of brain and heart in children following surgery of congenital heart disease are limited. Hence, this prospective, controlled and randomized study was designed to perform remote ischemic preconditioning in children after induction of anesthesia for pediatric heart surgery and to investigate the effect on postoperative organ function in comparison to a control group.

Detailed Description

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Arterial blood flow to the right leg of the patients is interrupted by inflating a cuff around the thigh up to a pressure of 15 mmHg above the systolic blood pressure for five minutes. Thereafter the pressure is released for another five minutes and the procedure is repeated fourfold. Cerebral and myocardial damage are examined by postoperative laboratory exams in comparison to preoperative baseline values. In addition to this, systemic immune response, renal function, duration of intensive care and time to discharge from hospital are compared between groups. Mechanisms of remote preconditioning are investigated by analyzing gene expression in human heart tissue obtained during surgery and in leukocytes.

The investigation is not associated with any known risks for the children.

Conditions

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Heart Ischemia Cerebral Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Remote ischemic preconditioning

Remote ischemic preconditioning at the left leg.

Group Type EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type OTHER

Remote ischemic preconditioning at the left leg.

Control

No ischemic preconditioning

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remote ischemic preconditioning

Remote ischemic preconditioning at the left leg.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* congenital heart surgery

Exclusion Criteria

* hypoplastic left heart syndrome
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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Axel Fudickar

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Axel Fudickar, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

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University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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Fudickar5

Identifier Type: -

Identifier Source: org_study_id